Duns Number:431529195
Device Description: SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to m SpaceFlex Hip Instrument Kit is intended to be used in combination with SpaceFlex Hip to mold temporary prosthesis.
Catalog Number
-
Brand Name
SpaceFlex Hip Instrument Kit
Version/Model Number
900008
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 04, 2019
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K192041
Product Code
KWL
Product Code Name
Prosthesis, Hip, Hemi-, Femoral, Metal
Public Device Record Key
a7276257-b923-41b0-921b-e2a544441611
Public Version Date
December 12, 2019
Public Version Number
1
DI Record Publish Date
December 04, 2019
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 1 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 23 |